bhpardo/ema_en · Datasets at Hugging Face

english stringlengths 2 1.37k
3
BATCH NUMBER
Possible side effects 5.
Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with a placebo.
Before administration the Aranesp solution should be inspected for visible particles.
In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine.
Cancer patients
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Actraphane 10 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Hyperkalaemia has been observed in isolated cases.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
How to store Aclasta 6.
Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required.
Hypersensitivity to the active substance or to any of the excipients.
Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Tel: +421 - 2 52638201
Ireland Roche Products (Ireland) Ltd.
Do not store above 30°C.
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
EXPIRY DATE
See Figure 2.
Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
These symptoms often develop before the symptoms of a low sugar level in the brain.
This metabolite is at least 13,000-fold less potent than tadalafil for PDE5.
6.2 Incompatibilities
Read the package leaflet before use.
After reconstitution, the solution is drawn through the sterile filter spike (supplied) into a sterile disposable syringe.
(10.1)
13 March 2007
Danmark Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Tyskland Tlf: +49 (0)69 1503 – 1
Caution is advised in patients taking anticoagulants and/ or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.
CLINICAL PARTICULARS
Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.
BATCH NUMBER
For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Aripiprazole is the predominant medicinal product moiety in systemic circulation.
These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 µg/ kg weekly and 3 to 9 µg/ kg every two weeks).
30 November 1995 Date of last renewal:
Keep out of the reach and sight of children.
In clinical studies, minimal accumulation was observed with either route of administration.
1, 5 and 10 cartridges x 3 ml.
The rate of increase in haemoglobin should be approximately 1 g/ dl
Treatment of diabetes mellitus.
BeneFIX powder for solution for injection can be stored below 25ºC for up to 1 month, without being refrigerated again during this period and must be discarded if not used after this.
12.
Possible side effects 5 How to store ABILIFY 6.
1.
Tel: +386 1 585 1767
Read the package leaflet before use.
22 10.
Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
4.6 Pregnancy and lactation
Tablet core:
How is Cervarix used?
The safety profile is based on treatment exposure to entecavir 1 mg once daily for a median of 69 weeks.
Amgen
VIAL LABEL FOR BEROMUN
Renals and Urinary Disorders
Talc (E553b) hypromellose (E464) titanium dioxide (E171) macrogol 8000
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with efavirenz in the presence of a PI (except fosamprenavir/ ritonavir where the dose should be 300 mg twice daily).
CellCept reduces your body’ s defence mechanism.
Concurrent administration with sympathomimetic medicines may result in critical hypertension reactions.
3.
Potential for ABILIFY to affect other medicinal products:
Oral use.
Dizziness was also seen in clinical studies with emtricitabine and tenofovir disoproxil fumarate.
In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species.
- if you have a severe liver insufficiency.
2.
Phenylketonurics:
70 mg 70 mg
4.7 Effects on ability to drive and use machines
CIALIS 5 mg is available in blister packs containing 14 or 28 tablets.
1 g contains:
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
What Aldurazyme contains
2.
For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.
31% (23%) 8% (2%)
Side effects reported in clinical studies for patients treated with Aprovel were:
Distribution The distribution volume of fondaparinux is limited (7-11 litres).
Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride.
3 ml
The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection.
Any unused product or waste material should be disposed of in accordance with local requirements.
Gently rotate the vial to dissolve the powder.
EU/ 1/ 07/ 412/ 019 EU/ 1/ 07/ 412/ 020
Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.
România S.C.
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
It has a dark blue injection button with a raised ring on the top.
In general, caution should be exercised in the administration and monitoring of APTIVUS in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.
BATCH NUMBER
SPECIAL STORAGE CONDITIONS
Common side effects (These can affect less than 1 person in 10 and more than 1 person in 100) • Irritation or discomfort in the inside of the nose – you may also get streaks of blood when you blow your nose.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
6.

3

BATCH NUMBER

Possible side effects 5.

Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with a placebo.

Before administration the Aranesp solution should be inspected for visible particles.

In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine.

Cancer patients

The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Actraphane 10 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.

Hyperkalaemia has been observed in isolated cases.

However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.

How to store Aclasta 6.

Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required.

Hypersensitivity to the active substance or to any of the excipients.

Uncommon - Diabetic retinopathy Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.

Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold.

Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.

Tel: +421 - 2 52638201

Ireland Roche Products (Ireland) Ltd.

Do not store above 30°C.

Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany

radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),

EXPIRY DATE

See Figure 2.

Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.

These symptoms often develop before the symptoms of a low sugar level in the brain.

This metabolite is at least 13,000-fold less potent than tadalafil for PDE5.

6.2 Incompatibilities

Read the package leaflet before use.

After reconstitution, the solution is drawn through the sterile filter spike (supplied) into a sterile disposable syringe.

(10.1)

13 March 2007

Danmark Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt Tyskland Tlf: +49 (0)69 1503 – 1

Caution is advised in patients taking anticoagulants and/ or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.

If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.

CLINICAL PARTICULARS

Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.

BATCH NUMBER

For information on the treatment of hyperglycaemia, see box at the end of this leaflet.

Aripiprazole is the predominant medicinal product moiety in systemic circulation.

These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 µg/ kg weekly and 3 to 9 µg/ kg every two weeks).

30 November 1995 Date of last renewal:

Keep out of the reach and sight of children.

In clinical studies, minimal accumulation was observed with either route of administration.

1, 5 and 10 cartridges x 3 ml.

The rate of increase in haemoglobin should be approximately 1 g/ dl

Treatment of diabetes mellitus.

BeneFIX powder for solution for injection can be stored below 25ºC for up to 1 month, without being refrigerated again during this period and must be discarded if not used after this.

12.

Possible side effects 5 How to store ABILIFY 6.

1.

Tel: +386 1 585 1767

Read the package leaflet before use.

22 10.

Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.

4.6 Pregnancy and lactation

Tablet core:

How is Cervarix used?

The safety profile is based on treatment exposure to entecavir 1 mg once daily for a median of 69 weeks.

Amgen

VIAL LABEL FOR BEROMUN

Renals and Urinary Disorders

Talc (E553b) hypromellose (E464) titanium dioxide (E171) macrogol 8000

CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with efavirenz in the presence of a PI (except fosamprenavir/ ritonavir where the dose should be 300 mg twice daily).

CellCept reduces your body’ s defence mechanism.

Concurrent administration with sympathomimetic medicines may result in critical hypertension reactions.

3.

Potential for ABILIFY to affect other medicinal products:

Oral use.

Dizziness was also seen in clinical studies with emtricitabine and tenofovir disoproxil fumarate.

In addition, rosiglitazone was not genotoxic in a battery of in vivo and in vitro genotoxicity studies and there was no evidence of colon tumours in lifetime studies of rosiglitazone in two rodent species.

- if you have a severe liver insufficiency.

2.

Phenylketonurics:

70 mg 70 mg

4.7 Effects on ability to drive and use machines

CIALIS 5 mg is available in blister packs containing 14 or 28 tablets.

1 g contains:

If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.

What Aldurazyme contains

2.

For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.

31% (23%) 8% (2%)

Side effects reported in clinical studies for patients treated with Aprovel were:

Distribution The distribution volume of fondaparinux is limited (7-11 litres).

Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride.

3 ml

The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection.

Any unused product or waste material should be disposed of in accordance with local requirements.

Gently rotate the vial to dissolve the powder.

EU/ 1/ 07/ 412/ 019 EU/ 1/ 07/ 412/ 020

Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and for more than 4 weeks.

România S.C.

Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

It has a dark blue injection button with a raised ring on the top.

In general, caution should be exercised in the administration and monitoring of APTIVUS in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.

BATCH NUMBER

SPECIAL STORAGE CONDITIONS

Common side effects (These can affect less than 1 person in 10 and more than 1 person in 100) • Irritation or discomfort in the inside of the nose – you may also get streaks of blood when you blow your nose.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

6.